Industry FDA Liaison Meeting
It was said...
"PTEI is an excellent source for the support of early stage research projects to enable data collection for latter stage funding. The funding program served as a nucleating agent to build new research collaborations."
William R. Wagner, PhD
Associate Professor, Surgery, Bioengineering and Chemical Engineering and Deputy Director, McGowan Institute for Regenerative Medicine, University of Pittsburgh
PTEI and the National Regenerative Medicine Foundation, in collaboration with the Tissue Engineering and Regenerative Medicine Society International, co-sponsored an April 28 liaison meeting with the Center for Biologics Research and Review (CBER/FDA) as a forum for discussion of FDA regulation and guidance on tissue-engineered products and to clarify scientific versus regulatory issues.
Chaired by Anthony Atala, MD, Director of the Wake Forest Institute for Regenerative Medicine, the meeting began with an overview by Dr. Celia Witten, Director, Office of Cellular Tissue and Gene Therapy, of the CBER approach to regulatory review and how FDA works with industry.
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To participate in a future FDA liaison meeting or join one of the working groups please contact Patrick Cantini.
Through this forum CBER representatives had the opportunity to listen to the concerns of the tissue engineering and regenerative medicine community related to issues of preclinical and clinical safety and efficacy, manufacturing processes and controls, and clarification of criteria for combination products.
More than 80 people attended, representing some 30 academic institutions in the U.S. and Canada as well as various departments within FDA. Presentations focused on three major issues:
Key Challenges in Clinical Translation of Tissue Engineering and Regenerative Medicine Products
Frederick Schoen, Harvard University
Release Criteria for Tissue Engineering/Regenerative Medicine Products
Tim Bertram, Wake Forest Institute for Regenerative Medicine
Manufacturing Issues Related to Tissue Engineering and Regenerative Medicine Products
Herb Bresler, Battelle
Working groups are developing guidelines for consideration by FDA. This information will be disseminated widely throughout the regenerative medicine community as it becomes available.
To participate in a future FDA liaison meeting or join one of the working groups please contact Patrick Cantini.